Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis

Sponsor

Mazandaran University of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04283747

Collaborator

(none)

170

Enrollment

Location

33.1

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

B cells are considered major contributors to multiple sclerosis (MS) pathogenesis, a role that has taken on renewed importance with the advent of B-cell-depleting therapies. Rituximab is being increasingly utilized as an off-label treatment option across MS patients .

In addition, there have been increasing reports of rituximab causing hypogammaglobulinaemia and antibody deficiency across a variety of conditions including MS and related neuroinflammatory disorders.

Therefore, the purpose of this study is to evaluate the rate of hypogammaglobulinemia in rituximab-treated MS adult patients and to assess the correlation with vaccination response during the treatment.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Hypogammaglobulinemia	Diagnostic Test: Serum immunoglobulin titer

Detailed Description

This is a prospective study which will be conducted in an educational medical hospitals in Sari, Iran.Adult patients with diagnosis of multiple sclerosis compatible with 2017 McDonald criteria and history of treatment with rituximab at least 3 times( 18 month) , enrolled to this study.Demographic patients' characteristics, including age, sex, vital sign, past medical history, drug history, will be recorded. Disease duration prior to rituximab, total rituximab dose, prior immunomodulatory drugs, Adverse drug reactions, the time interval between the last rituximab infusion and need for intravenous immunoglobulin replacement therapy and infections are recorded. Moreover, we will assess IgG and IgM levels, VZV titer at before rituximab administration and 6, 12, 18, months following the initiation of next dose of rituximab.

Study Design

Study Type:

Observational

Anticipated Enrollment :

170 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Hypogammaglobulinemia and Immunization Responses to Measles in Rituximab-treated Multiple Sclerosis Patients

Actual Study Start Date :

Feb 28, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Rate of hypogammaglobinemia [every 6 month until 18 month]
serum IgG concentration lower than g/L,

Secondary Outcome Measures

severity of hypogammaglobinemia [every 6 month until 18 month]
serum IgG concentration: mild (at risk) 5- 6.9 g/L, moderate 3- 4.9 g/L and severe < 3 g/L
immunization response to VZV vaccination [every 6 month until 18 month]
change of VZV antibody titre
Rate of infection [during 18 month of fallow up]
number of all infection events
type of infection [During 18 month of study]
infections in different organs
severity of infection events [During 18 month of study]
need for hospitalization, oral or intravenous antibiotic therapy